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Pfizer/BioNTech Complete European Submission For Omicron Subvariant Adapted Vaccine

·1 min read
  • Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have completed a submission to the European Medicines Agency (EMA) for a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for 12 years and older.

  • Except for the addition to the mRNA of the Omicron BA.4/BA.5 spike protein sequence, all other vaccine components remain unchanged.

  • Related: Boosters Are Coming For Dangerous Omicron COVID-19 Variant. Here's Who May Be Rolling Them Out.

  • Preclinical data showed that a booster dose of omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against omicron subvariants.

  • Related: Pfizer/BioNTech's COVID-19 Vaccine Updated Data Shows Around 76% Efficacy In Toddlers.

  • The companies have also provided safety data from clinical trials evaluating multiple variant-adapted vaccine candidates based on previous variants of concern.

  • Pfizer and BioNTech also applied with the EMA for the Omicron BA.1-adapted bivalent COVID-19 vaccine in July, which is currently under review by the Agency. The Omicron BA.1-adapted and Omicron BA.4/BA.5-adapted bivalent boosters will be available to ship shortly after respective regulatory authorizations and be available for use as early as September.

  • Price Action: PFE shares are down 1.39% at $47.24, and BNTX stock is down 2.05% at $145.52 on the last check Friday.

  • Photo via Wikimedia Commons

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